Johnson & Johnson announced on Monday that it has submitted a request to the U.S. Food and Drug Administration (FDA) to broaden the approval of its ketamine-based medication, Spravato, for use as a standalone therapy for treatment-resistant depression.
Spravato was initially approved by the FDA in 2019 for use in conjunction with an oral antidepressant for patients who have not seen improvement after trying two or more antidepressants. According to Johnson & Johnson, nearly 30 percent of the estimated 280 million people worldwide suffering from major depressive disorder experience treatment-resistant depression.
Bill Martin, head of neuroscience at Johnson & Johnson, stated in a press release, “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones.”
The application for expanded use was supported by data from a recent late-stage clinical trial, which indicated that Spravato, administered as a standalone treatment, could alleviate patients’ symptoms as soon as 24 hours after administration and sustain that relief for at least four weeks.
Spravato is delivered as a nasal spray and must be administered under the supervision of a healthcare provider in a clinical setting. Unlike traditional antidepressants that affect chemicals such as serotonin and dopamine, Spravato acts by enhancing glutamate levels in the brain, the most prevalent neurotransmitter that facilitates neuron communication.
Sales of Spravato surged by 60%, reaching $271 million in the quarter ending June 30, compared to the same quarter in 2023. The medication has been utilized by approximately 100,000 individuals across 77 countries, as reported by Johnson & Johnson.